FDA.reportPublic FDA data

Application 021894

Type
NDA
Sponsor
VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XENAZINETETRABENAZINETABLET;ORAL12.5MGYesNo
002XENAZINETETRABENAZINETABLET;ORAL25MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67386-421XenazinetetrabenazineLundbeck Pharmaceuticals LLCNDACurrent
67386-421XenazinetetrabenazineLundbeck Pharmaceuticals LLCNDACurrent
67386-421XenazinetetrabenazineLundbeck Pharmaceuticals LLCNDACurrent
67386-421XenazinetetrabenazineLundbeck Pharmaceuticals LLCNDACurrent
67386-421XenazinetetrabenazineLundbeck Pharmaceuticals LLCNDACurrent
67386-422XenazinetetrabenazineLundbeck Pharmaceuticals LLCNDACurrent
67386-422XenazinetetrabenazineLundbeck Pharmaceuticals LLCNDACurrent
67386-422XenazinetetrabenazineLundbeck Pharmaceuticals LLCNDACurrent
67386-422XenazinetetrabenazineLundbeck Pharmaceuticals LLCNDACurrent
67386-422XenazinetetrabenazineLundbeck Pharmaceuticals LLCNDACurrent
68682-421tetrabenazinetetrabenazineOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-421tetrabenazinetetrabenazineOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-422tetrabenazinetetrabenazineOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-422tetrabenazinetetrabenazineOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49816SUPPL2017-09-21
49815SUPPL2017-09-21
49802SUPPL2017-09-19
6402SUPPL2015-08-27
28800SUPPL2015-06-04
16531SUPPL2015-06-04
28799SUPPL2013-08-05
6401SUPPL2012-08-27
28798SUPPL2011-07-07
16530SUPPL2011-07-07
6400SUPPL2011-05-06
37837SUPPL2011-05-05
28797SUPPL2010-01-27
28796SUPPL2010-01-27
24225ORIG2008-10-09
21861ORIG2008-10-09
37836ORIG2008-08-26
6399ORIG2008-08-21